Thromboembolism Clinical Trial
Official title:
Direct Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement.---A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Enoxaparin
The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.
Status | Completed |
Enrollment | 1141 |
Est. completion date | August 2007 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Scheduled for elective primary hip replacement - Age 18 years or over - Written informed consent obtained Exclusion Criteria: - Documented history or considered at increased risk of venous thromboembolism - Subjects considered at increased risk of bleeding - Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment - Concomitant use of anticoagulants/ antiplatelet agents |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc | Astellas Pharma Europe B.V. |
Austria, Bosnia and Herzegovina, Czech Republic, Denmark, Finland, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Russian Federation, Serbia, Slovakia, Spain, Sweden,
Eriksson BI, Turpie AG, Lassen MR, Prins MH, Agnelli G, Kälebo P, Wetherill G, Wilpshaar JW, Meems L; ONYX-2 STUDY GROUP. Prevention of venous thromboembolism with an oral factor Xa inhibitor, YM150, after total hip arthroplasty. A dose finding study (ONYX-2). J Thromb Haemost. 2010 Apr;8(4):714-21. doi: 10.1111/j.1538-7836.2010.03748.x. Epub 2010 Jan 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of total venous thromboembolism (VTE) during hospitalization phase | |||
Primary | Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major | |||
Secondary | Proximal or distal deep vein thrombosis (DVT) during hospitalization phase | |||
Secondary | Symptomatic VTE | |||
Secondary | Rate of total VTE | |||
Secondary | Death due to any cause during treatment | |||
Secondary | Incidence of the bleeding types: | |||
Secondary | Major or clinically relevant non-major bleeding, Major bleeding, | |||
Secondary | Clinically relevant non-major bleeding, Minor bleeding |
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